Senior Director, Quality - Bioscience

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Your Opportunity

Responsibilities

The Senior Director, Quality leads the organization's Quality Assurance, Quality Control and Regulatory Affairs organization and oversees and supervises all aspects of quality and regulatory compliance. The Senior Director, Quality manages QA, QC, and RA teams as well as manages relationships with, and performance by, key service partners such as raw material suppliers and contract laboratories. The ideal candidate has a strong understanding of current Good Manufacturing Practice regulations, excellent communication skills, and substantial experience in quality assurance. Specific responsibilities include:

• Ensuring compliance with regulatory, FDA, customer, and internal cGMP requirements.
• Establishing a strong Quality and compliance culture.
• Overseeing the manufacture and testing of products that conform to specifications.
• Identifying, monitoring and mitigating risks.
  
  

The incumbent also leads interactions with Customers, Product Development, Sales and Supply Chain leadership to develop systems and procedures that meet internal and customer quality requirements. The Senior Director, Quality maintains a close relationship with Operations and leverages R&D initiatives to manufacture high quality products, and achieve quality design and production goals.

The Senior Director, Quality works with Senior Leadership in the identification of strategic goals and plans, advises company management in FDA regulatory policy and program matters, and recommends appropriate courses of action, along with overseeing relationships with Customers to ensure accurate technical information, specifications and resolve customer complaints.

Core Responsibilities

• Oversees the quality management system and reports regularly to Company management on the state of the Quality system.
• Sets Quality unit directions and goals, providing overall Quality leadership that fosters a strong compliance culture and promotes compliance with relevant regulations.
• Leads regulatory and customer inspections, prepares written responses to findings/observations, and develops effective action plans to address any identified issues.
• Supervises the internal and external audit programs.
• Manages the site’s supplier qualification program, including audits, preparation of audit reports, assessment of CAPAs, and verification of CAPA effectiveness.
• Oversees deviation, complaint and laboratory OOS investigations as well as the implementation of effective CAPAs.
• Manages the site’s validation program, including review and approval of equipment, process, cleaning and water system validation protocols and reports.
• Creates procedures and work instructions that promote conformance to product specifications and regulatory requirements.
• Establishes a collaborative relationship with leadership, operations, sales, marketing and other internal departments and outside service providers.
• Manages the design and implementation of effective training programs for QC, QA RA and Operations personnel, including training on regulatory requirements and data integrity/Good Documentation Practice (GDP).
• Prepares and maintains the company’s Drug Master Files (DMF).
• Participates in the new project design team, including reviewing new products, product design and product packaging, and making recommendations regarding quality and compliance .
• Acts as Project Coordinator and/or Project Leader as assigned for special projects.
• Represents the Company in discussions with customers, suppliers, auditors, and regulatory agencies (FDA, EMA, etc.).
• Achieve financial objectives by preparing and managing the Quality unit budgets and related reports.
• Trains, coaches and counsels QC, QA, and RA Managers in the activities of their departments to improve quality and compliance and enhance safety.
• Initiates and handles personnel actions such as hires, transfers, promotions, discipline and terminations.
• Meets and exceeds FDA and industry standards, achieving best-in-class adherence in the areas of safety and product quality.
  
  

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions.

• Bachelor’s degree from an accredited four-year college or university in Analytical Chemistry or related field and 12 years of relevant experience in the pharmaceutical industry; or equivalent combination of education and experience, required.
• 5 years of demonstrated experience in team management/development.
• Strong working knowledge of FDA regulations, including 21 CFR Parts 11, 210, and 211, ICH Q7 and related FDA Guidance documents.
• Qualification as a Certified Quality Auditor (CQA) through the American Society for Quality (ASQ) is desirable.
• Excellent communication, planning, problem-solving, analytical, and organizational skills.
• Detail oriented; able to deal with multiple changing priorities and able to work with minimal supervision.
• Proficiency in data analysis and reporting. Applied knowledge of Word and Excel required. Knowledge of Inventory and Manufacturing software; Spreadsheet and Word Processing software; and major enterprise ERP(s) is a plus.
• Ability to uphold regulatory, company, and customer standards.
• Skilled at quality principles, pharmaceutical manufacture and Quality Management Systems (QMS).
• Must be able to travel as needed.
  
  

Supervisory Responsibilities

• Provides leadership and guidance to employees in the Quality Control, Quality Assurance, and Regulatory Affairs departments
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and assisting in providing appropriate resolutions.
  
  

IndSPR-Corp

Relocation Package Available

Yes

Eligible For Company Vehicle

No

EEO Information

Smithfield is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non-job characteristic as directed by law.

If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at 757-357-1595.